Shares in Poland's Mabion surge on Novavax vaccine programme deal

 Shares in Mabion, a Polish biotechnology company, jumped by over 60% on Wednesday morning after it announced a framework cooperation deal with U.S. vaccine developer Novavax on COVID-19 vaccination technology.

"We look forward to a close cooperation with Novavax, which may pave the way for commercial scale production, provided that technology transfer and technical batch are successfully completed", Mabion Chief executive Dirk Kreder said in a statement.

Under the terms of the agreement, Mabion and Novavax will work together to transfer technology for the production of a technical batch of NVX-CoV2373.

Mabion said it expected the technology transfer and verification to complete by the middle of 2021.

"Upon successful completion, Mabion's manufacturing facility could become a part of the supply chain for commercial production of Novavax's adjuvanted protein-based vaccine candidate," Mabion said in a statement.

By 0920 GMT shares in Mabion were up 42.2% at 44.5 zlotys, valuing the company at around 611 million zlotys ($162.79 million).

Mabion was established in 2007 by four Polish pharmaceutical companies - Celon Pharma, Polfarmex, IBSS Krakow and Genexo.

Poland, with a population of around 38 million, has up to date inoculated over 3 million people, mostly with vaccines by Pfeizer, Moderna and AstraZeneca. Like in other EU countries, the programme has been hampered by delays in deliveries.

https://finance.yahoo.com/news/shares-polands-mabion-surge-novavax-093216311.html

Heat Biologics started at Overweight by Cantor

 Target $22

https://finviz.com/quote.ashx?t=HTBX

Is Vaxart Stock Set To Decline Further?

Vaxart  (NASDAQ: VXRT) dropped -8% over the last five trading days and has underperformed the S&P 500 which remained roughly flat over the same period. The stock is also down by about -27% over the last month (twenty-one trading days), although it remains up by 29% year-to-date. Vaxart stock has seen a lot of volatility this year, rallying considerably in late January, in anticipation of the phase 1 data readout for the company’s tablet-based Covid-19 vaccine candidate and also due to increased attention from retail investors who were betting on small stocks with high short interest, following the GameStop short squeeze. However, the stock plummeted in early February after early-stage data indicated that the vaccine provided a lackluster antibody response against the Coronavirus. (see our updates below) Now, is Vaxart stock set to decline further or should we expect a recovery? There is a 53% chance that Vaxart stock will decline over the next month based on our machine learning analysis of trends in the stock price over the last five years. See our analysis on VXRT Stock Chances Of Rise for more details.

Overall, we think Vaxart stock looks somewhat risky at current levels of around $7.50 per share. The antibody response is the yardstick by which investors have been judging the potential efficacy of Covid-19 vaccines in phase 1 trials and Vaxart’s candidate fared badly on this front, failing to induce neutralizing antibodies in most trial subjects. In contrast, shots from Pfizer (NYSE: PFE) and Moderna (NASDAQ: MRNA) produced antibodies in 100% of participants in phase 1 trials. Apart from the efficacy concerns, the company’s development timeline also trails behind market leaders by multiple quarters. Vaxart has no revenue-generating products yet, with the most advanced development in its pipeline being a vaccine for seasonal influenza which is currently in phase 2 trials. Even after the big sell-off, the stock remains up by about 6x over the last 12 months.

https://www.nasdaq.com/articles/is-vaxart-stock-set-to-decline-further-2021-03-03

GSK, Vir hit as COVID-19 drug hopeful halted on possible weak efficacy in key NIH phase 3

 GlaxoSmithKline and partner Vir Biotechnology have seen a key, late-stage test of their experimental COVID-19 drug stopped for new patients amid concerns it may not be working well enough.

In an update Wednesday morning, the two partners said a study of VIR-7831, a dual-action SARS-CoV-2 monoclonal antibody, would see enrollment stopped as an independent data monitoring board said “sensitivity analyses of the available data raised concerns about the magnitude of potential benefit.”

It recommends that the VIR-7831 arm of the trial “be closed to enrollment while the data mature.” The so-called ACTIV-3 program, started in December last year, was part of a new sub-trial with the National Institutes of Health (NIH) assessing the med in hospitalized adults with COVID-19.

GSK and Vir, which partnered up last year and have other tests for the drug still ongoing (which are not affected by this stop), said they “will continue discussions with the NIH about appropriate ways to further assess the potential of VIR-7831 in the hospitalized population as all parties gain a fuller understanding of the still-emerging data.”

This heaps more woe onto GSK, which has already been hit by a major setback in its vaccine efforts against COVID-19, and drug R&D against the virus in general, which has seen a number of repurposed drugs as well as experimental efforts from companies like Merck flop or be hit by trouble.

Both companies said safety was not an issue in the 300 dosed patients from the test.

“While we are disappointed with the recommendation of the DSMB, we are encouraged by the safety profile of VIR-7831 and by the possibility of a benefit on top of remdesivir and corticosteroids in this advanced cohort of patients#,” said Vir CEO George Scangos, Ph.D.

 “We want to thank the patients who participated in this study and the NIH for investing in the ACTIV trial to evaluate the four monoclonal antibodies, as it recognizes the need for differentiated treatments, especially as new variants emerge globally,” added Christopher Corsico, M.D., senior vice president of development at GSK.

“These and other anticipated data will provide valuable insights about how VIR-7831 can contribute to the fight against this pandemic.”

Vir’s shares tumbled nearly 30% on the news, while GSK was flat.

https://www.fiercebiotech.com/biotech/gsk-vir-hit-as-covid-drug-hopeful-halted-possible-weak-efficacy-key-nih-phase-3

US nursing homes see 82% decline in COVID-19 cases since vaccines began

 Nursing homes in the United States have seen a huge drop in new COVID-19 cases this year — suggesting that coronavirus vaccines are working, a report released Tuesday said.

There was a dramatic 82 percent decline in new cases among US nursing home residents since the peak during the week of Dec. 20, according to the report by the American Health Care Association and National Center for Assisted Living. That week, there were more than 33,000 new cases and on Feb. 7, just 6,077 cases were recorded.

By comparison, COVID-19 cases in the general population dropped by just 46 percent.

The report, which uses data from the federal Centers for Medicare and Medicaid Services, shows that COVID-19-related deaths in nursing homes also dropped by 63 percent between Dec. 20 when 5,932 deaths were logged and Feb. 7 when 2,211 fatalities were recorded

Coronavirus vaccination efforts kicked off in the US in mid-December with nursing home residents and staffers among the first prioritized.

“We still have a long road ahead, but these numbers are incredibly encouraging and a major morale booster for frontline caregivers who have been working tirelessly every day for a year to protect our residents,” Mark Parkinson, the president and CEO of AHCA/NCAL, said in a statement.

“This new data showcases just how important it is for nursing homes residents and staff, as well as the general public, to get the vaccine because it is clearly working.”

The Centers for Medicare and Medicaid Services started tracking new COVID-19 cases in nursing homes nationwide back in May last year when more than 10,000 new cases were logged.  

That figure dropped to about 6,890 in September, but then skyrocketed throughout October, November and December before plummeting to 6,077 on Feb. 7, the data shows.

“Though this report brings hope, we cannot let our guard down. We must continue to encourage folks to get vaccinated, especially caregivers and staff,” said Parkinson.

Additionally, Parkinson said the organization is calling on the Biden administration “to review its current guidance to nursing homes on restricting visitors and group activities.”

“With millions of residents and caregivers now fully protected thanks to the vaccines, residents must be able to safely reengage in meaningful activities and be reunited with their loved ones,” said Parkinson.

https://nypost.com/2021/03/02/us-nursing-homes-see-82-decline-in-covid-19-cases-after-vaccines-began/

European Officials Seek To Garner Support For AstraZeneca COVID-19 Shot

 

• European officials are under pressure to reverse restrictions on who can receive the Oxford-AstraZeneca Plc’s (NYSE: AZN) coronavirus vaccine and attract support for the shot, CNBC reports.
• Monday, France recommended the AstraZeneca shot to anyone under 75 (up from a previous age limit of 65), including those with pre-existing health problems.
• Speaking to the BBC, Carsten Watzl, head of the German Society for Immunology, urged Chancellor Angela Merkel to take the vaccine live on TV to show it’s safe.
• The European Medicines Agency approved the AZN-Oxford vaccine in January. Still, France and Germany’s health regulators, among others in Europe, only approved the vaccine for the under-65s, saying there was not enough evidence to prove the vaccine’s effectiveness in the higher age group.
• South Africa halted the use of AstraZeneca’s vaccine after a small early data suggested that AZN’s jab has limited protection against mild disease caused by the variant.
• Earlier yesterday, Reuters reported that real-world data involving older age groups have shown that the AstraZeneca-Oxford University vaccine effectively prevents COVID-19 infection, hospitalizations, and deaths.
• WHO listed two versions AZN-Oxford’s vaccine for emergency use and said the vaccines are safe for those above 18 years old, including those over 65.

https://www.benzinga.com/general/biotech/21/03/19944457/european-officials-seek-to-garner-support-for-astrazeneca-covid-19-shot-cnbc

KemPharm Shares Trade Higher After FDA Approval For Azstarys In ADHD

 

• The FDA has approved KemPharm Inc's (NASDAQ: KMPH) market application for Azstarys (formerly referred to as KP415), a once-daily product for the treatment of attention deficit hyperactivity disorder (ADHD) in patients age six years and older.
• ADHD is a neurobehavioral disorder of childhood that makes it difficult for a person to pay attention and control impulsive behaviors.
• AZSTARYS consists of serdexmethylphenidate, KemPharm's prodrug of d-methylphenidate (d-MPH), co-formulated with immediate-release d-MPH.
• Azstarys will be commercially available in the U.S. as early as the second half of 2021.

https://www.benzinga.com/general/biotech/21/03/19978031/kempharm-shares-trade-higher-after-fda-approval-for-azstarys-in-adhd